The Management of HIV infected Healthcare Workers who perform exposure prone procedures: updated guidance, January 2014

Withdra

wn Feb

ruary

2021

2

About Public Health England

Public Health England’s mission is to protect and improve the nation’s

health and to address inequalities through working with national and local government, the NHS, industry and the voluntary and community sector. PHE is an operationally autonomous executive agency of the Department of Health.

Public Health England 133-155 Waterloo RoadWellington HouseLondon SE1 8UGTel: 020 7654 8000www.gov.uk/pheTwitter: @PHE_ukFacebook: www.facebook.com/PublicHealthEngland

© Crown copyright 2014 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence v2.0. To view this licence, visit OGL or email psi@nationalarchives.gsi.gov.uk. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Any enquiries regarding this publication should be sent to [insert email address].

Published January 2014 PHE publications gateway number: 2013439 With

drawn F

ebrua

ry 20

21

3

Contents

1. Risk of health care transmission from Healthcare Worker to patient 4

2. HIV testing of Healthcare Workers 5

3. Management of HIV infected Healthcare Workers 6

4. Occapational health monitoring arrangements 10

5. Treatment issues 14

6. Patient notification exercises 14

7. Management of patient following exposure 15

Appendix

References

NOTE: This guidance will be included within consolidated guidance on HIV, HBV and HCV healthcare workers who conduct exposure prone procedures, to be published in April 2014.With

drawn F

ebrua

ry 20

21

4

1. Risk of health care transmission from HCW to patient

Worldwide, there have been three reports of health care associated HIV

transmission from infected healthcare workers (HCWs) during exposure prone

procedures (EPPs); a Florida dentist1, where the exact risk of transmission

was never established; a French orthopaedic surgeon2; and a gynaecologist

in Spain3. In the last two cases transmission occurred during category 3 EPP1.

A further transmission has been reported involving a French nurse who was

co-infected with hepatitis C4; this did not involve an EPP and the exact route

of transmission remains unclear. Genetic relatedness of virus in the HCW and

patient(s) was demonstrated in all four cases. These four cases of

transmission involved HCWs who were not taking antiretroviral therapy at the

time of transmission.

A report from a Tripartite Working Group of the Expert Advisory Group on

AIDS (EAGA), the UK Advisory Panel for Healthcare Workers Infected with

Blood-borne Viruses (UKAP) and the Advisory Group on Hepatitis (AGH)

concluded that the risk of HIV transmission from an infected and untreated

HCW to a patient during EPPs is extremely low for the most invasive

procedures (category 3) and negligible for less invasive procedures (category

1).

The data available from patient notification exercises (PNEs) support the

conclusion that the overall risk of transmission of HIV from infected HCW to

patients is very low. Between 1988 and 2008, 39 PNEs involving HIV infected

1 EPPs are those invasive procedures where there is a risk that injury to the worker may result in exposure of the patient’s open tissues to the blood of the worker. These include procedures where the worker’s gloved hands may be in contact with sharp instruments, needle tips or sharp tissues (eg spicules of bone or teeth) inside a patient’s open body cavity, wound or confined anatomical space where the hands or fingertips may not be completely visible at all times. Such procedures occur mainly in surgery, obstetrics and gynaecology, dentistry and some aspects of midwifery. Most nursing duties do not involve EPPs; exceptions include accident and emergency and theatre nursing. Further guidance and examples of EPPs can be found in Department of Health. HIV Infected Health Care Workers: guidance on management and patient notification. London; 2005. http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4116415

Withdra

wn Feb

ruary

2021

5

HCWs were undertaken in the UK and reported to UKAP. No cases of HCW

to patient HIV transmission were identified despite almost 10,000 patients

having been tested5. The Tripartite Working Group report estimated the risk of

HIV transmission to any patient having the most invasive type of EPP from

any HCW, to be between one in 33,000 and one in 833,000 5.

The risk of HIV transmission from an infected HCW during an EPP can be

reduced even further by combination antiretroviral therapy (cART), if the

HCW’s viral load is suppressed to a very low or undetectable level.

2. HIV testing of HCWs

All new HCWs employed or starting training (including students) in a clinical

care setting, either for the first time or returning to work in the NHS should

undergo standard health checks which will include being offered an HIV

antibody test. HCWs who will perform EPPs must be tested for HIV antibody6.

HCWs who apply for a post or training which requires the performance of

EPPs and who decline to be tested for HIV, hepatitis B and hepatitis C should

not be cleared for EPP work.

Appropriate pre-test discussion should include reference to their professional

responsibilities in relation to HIV, and a reminder of the ways in which they

may have been exposed to HIV, which include:

a) if they are male, engaging in unprotected sexual intercourse with

another man

b) having unprotected intercourse in, or with a person who had been

exposed in a country where transmission of HIV through sexual

intercourse between men and women is common

c) sharing injecting equipment while using drugs

d) having a significant occupational exposure to HIV infected material in

any circumstances

e) engaging in invasive medical, surgical, dental or midwifery procedures,

either as a practitioner or patient, in parts of the world where infection-

Withdra

wn Feb

ruary

2021

6

control precautions may have been inadequate, or where the

population prevalence of HIV infection is high

f) engaging in unprotected sexual intercourse with someone who may

have been exposed to HIV through any of the above categories Practising HCWs who undertake EPPs are under a professional duty to seek

medical advice on the need to be tested as soon as they are aware they may

have been exposed to HIV infection, occupationally or otherwise (eg if they

meet any of the preceding exposure criteria a-f) and if found to be positive, to

obtain and follow appropriate clinical and occupational health advice.

Being HIV positive, or declining a test for HIV, will not affect the employment

or training of HCWs who will not perform EPPs.

3. Management of HIV infected HCWs

HIV infected HCWs must meet the following criteria before they can perform

EPPs:

Either

a) be on effective combination antiretroviral therapy (cART), and

b) have a plasma viral load <200 copies/ml

Or

c) be an elite controller2

And

d) be subject to plasma viral load monitoring every three months and

e) be under joint supervision of a consultant occupational physician and

their treating physician, and

f) be registered with the UKAP Occupational Health Monitoring Register

(UKAP-OHR)

2 An elite controller is defined as a person living with HIV who is not receiving antiretroviral therapy and who has

maintained their viral load below the limits of assay detection for at least 12 months, based on at least three separate viral load measurements

Withdra

wn Feb

ruary

2021

7

3.1 Initial health clearance for HIV infected HCWs who wish to perform EPPs

For HCWs wishing to perform EPPs, two Identified and Validated blood

Sample (IVS) test results taken no less than three months3 apart and with viral

load levels below 200 copies/ml are required to ensure viral load stability. At

this point, a decision should be made as to whether health clearance could be

given for the HCW to commence or resume EPP activities.

For HCWs currently restricted from EPPs who are on combination cART with

undetectable viral load (below 200 copies/ml), one IVS at least 12 weeks

since their last undetectable viral load is sufficient proof on which to grant

clearance for conducting EPPs.

The decision to clear individual HCWs for work involving EPPs is the

responsibility of the consultant occupational physician in consultation with the

treating physician. UKAP may be consulted on the application of the policy, as

needed (see Appendix for contact details).

3.2 Viral load monitoring and ongoing clearance for HIV infected HCWs performing EPPs

HIV infected HCWs who are cleared to perform EPPs are subject to viral load

testing every three months4 while continuing to perform such procedures. The

three month period should be taken from the date the previous IVS5 was

drawn, and not from the date the result was received.

If a HCW’s plasma viral load rises above 1000 copies/ml, they should be

restricted immediately from carrying out EPPs until their viral load returns to

3 For the purposes of initial health clearance, no less than 3 months apart is defined as between 12 and 16 complete calendar weeks. 4 Quarterly viral load testing can be performed no earlier than 10, and no later than 14 complete calendar weeks after

the date of the preceding specimen taken for OH monitoring purposes 5 An IVS is defined by Association of NHS Occupational Physicians (ANHOPS) and the Association of NHS

Occupational Health Nurses (ANHONS) as meeting the following criteria (a) the healthcare worker should show a proof of identity with a photograph – Trust identity badge, new driver’s licence, passport or national identity card – when the sample is taken; (b) the sample of blood should be taken in the occupational health department; (c) samples should be delivered to the laboratory in the usual manner, not transported by the healthcare worker; (d) when results are received from the laboratory, the clinical notes should be checked for a record that the sample was sent by the occupational health department, at the relevant time

Withdra

wn Feb

ruary

2021

8

being consistently below 200 copies/ml in at least two tests done no less than

three months apart. The significance of any increase in plasma viral load

above 200 copies/ml and below 1000 copies/ml should be assessed jointly by

the occupational health and treating physicians with input from appropriate

local experts (eg consultant virologist or microbiologist).

The table below sets out the expected course of action for viral load test

results below and above the level for EPP clearance (200 copies/ ml).

Viral load count test result Action

<50 copies/ml or below No action – retest in three months 50-200 copies/ml A case-by-case approach based on

clinical judgement would be taken which

may result in no action (as above) or a

second test may be done 10 days later to

verify the first result. Further action

would be informed by the test result. >200 copies/ml but <1000 copies/ml A second test should automatically be

done 10 days later on a new blood

sample to verify the first result. If the

count was still in excess of 200

copies/ml, the HCW would cease

conducting EPPs until their count, in two

consecutive tests no less than three

months apart, was reduced to <200

copies/ml. 1000 copies/ml or above The HCW would cease conducting

EPPs immediately. A second test must be done on a new blood sample 10

days later to verify the first result. If the

count was still in excess of 1000

copies/ml, a full risk assessment should

be initiated to determine the risk of HCW

to patient transmission. At a minimum,

this will include discussion between the

Withdra

wn Feb

ruary

2021

9

consultant occupational physician and

the treating physician on the significance

of the result to the risk of HIV

transmission. Following a risk assessment exercise, a

Patient Notification Exercise (PNE) may

be indicated6. UKAP advice may be

sought at this stage.

3.3 Failure to attend or refusal to test

All HCWs performing EPPs should be advised by their consultant

occupational physician and their treating physician of the importance of

quarterly monitoring of their viral load and the implications of not doing so.

Where a HCW does not attend for their appointments, or refuses to have their

viral load tested, the consultant occupational physician should inform the

HCWs manager that they are no longer cleared to perform EPPs, until it has

been established that the HCW is continuing with cART and their viral load

(measured within the past three months) does not exceed 200 copies/ml.

3.4 Resuming EPPs

Resumption of EPP activities following a period of interruption (for whatever

reason) requires demonstration of consistent viral load suppression to very

low or undetectable levels ie at least two viral loads below 200 copies/ml, no

less than three months apart.

3.5 Elite controllers

Elite controllers comprise a small proportion (0.2-0.55%) of all people living

with HIV, who are not receiving antiretroviral therapy and have maintained

6 Guidance on performing a local risk assessment can be found at http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317133297795

Withdra

wn Feb

ruary

2021

10

their viral load below the limits of assay detection for at least 12 months,

based on at least three separate viral load measurements.

A HCW who meets the definition of being an elite controller can be cleared for

EPP activities without being on treatment, but remains subject to three-

monthly viral load monitoring to ensure they maintain their viral load below

200 copies/ml and to identify any rebound promptly. Any such cases should

be referred to UKAP for advice on a case-by-case basis.

4. Occupational health monitoring arrangements for HIV infected HCWs

The model for allowing HIV infected HCWs to undertake EPPs whilst on

therapy relies on continuing care and regular viral load monitoring by their

treating physician and consultant occupational physicians. Effective

monitoring requires close working between these two parties to ensure that

the policy is being adhered to appropriately, thus minimising the risk of

transmission.

Where a healthcare establishment’s occupational health service does not

have its own consultant occupational physician, arrangements should be put

in place for this advice to be sought from such a consultant outside the

establishment. Suitable arrangements must be in place for agency or locum

staff, including dental staff, to ensure that they have a designated consultant

occupational physician who is responsible for their monitoring, in accordance

with this guidance.

All HIV infected HCWs who perform EPPs should have their viral load

measured every three months using a blood IVS. Blood testing for this

purpose will usually be carried out by the Occupational Health Service but

where this would give rise to duplication of testing, local arrangements should

be made between the treating physician and the occupational health service

to ensure that blood drawn from HIV infected HCWs for viral load

Withdra

wn Feb

ruary

2021

11

measurements in GUM or infectious diseases settings follows the principles of

an IVS (see footnote5).

To support and monitor implementation of the policy and to ensure patient

safety, all HIV infected HCWs, including locum and agency staff, who wish to

perform EPPs, and who meet the criteria for clearance must have the

outcome of their monitoring promptly reported by the relevant occupational

health department to a central confidential register, the UKAP-Occupational

Health Monitoring Register of Blood Borne Virus Infected HCWs (UKAP-OHR)

(www.ukap-ohr.org.uk), managed by Public Health England (on behalf of

Health Protection Scotland, Public Health Wales, and the Public Health

Agency for Northern Ireland) and overseen by the UKAP. Each HCW must be

recorded on the register by their designated consultant occupational

physician. The ongoing viral load monitoring data will be updated by

occupational health providers on a regular basis via a web-based data entry

system. Action taken as a result of an increase in viral load should be reported

using the register to record that, restrictions on practice are put in place

appropriately and, where necessary, risk assessments and patient notification

exercises are carried out.

The UKAP-OHR will be securely and confidentially administered. Access to

the individual records of the HCWs on the register will be strictly limited to the

designated consultant occupational physicians responsible for the care,

monitoring, management and EPP clearance of the HCW, and those who

have delegated authority for this within occupational health, and to those few

authorised individuals, managing the register on behalf of UKAP.

Whilst it is important that UKAP should be called upon for advice on the

application of the policy as needed, decisions to clear individual HCWs for

EPP work will ultimately remain the responsibility of the treating and

occupational health physicians.

Withdra

wn Feb

ruary

2021

12

The roles and responsibilities of the respective individuals involved in the

monitoring process for HIV infected HCWs performing EPPs are set out in the

Table below:

A. Health care worker

Must be under the care of a designated consultant occupational physician Must accept that it is a condition of undertaking EPPs that they consent to ongoing monitoring while they continue to practise exposure-prone procedures, including:

i. the registration of their details and monitoring data on the UKAP-OHR

ii. the release of monitoring information to the consultant occupational physician and the treating physician

iii. to provide an IVS for viral load monitoring at the appointed times iv. to seek advice if change in health condition may affect their fitness to

practise or impair their health v. to notify OH when they are changing their practice or their place of

employment Thus, HCWs must agree that by seeking to and undertaking EPPs, they are giving implied consent to i and ii above and they are undertaking to satisfy iii, iv and v as well.

B. Consultant occupational physician The consultant occupational physician is responsible for the monitoring of the infected HCW including:

i. ensuring that the testing protocol and timings are followed ii. reacting promptly to any alerts received via UKAP-OHR iii. taking appropriate action when those who should present for tests do

not do so eg notifying the relevant manager of the HCW’s non-attendance and restriction from EPP practice

iv. taking IVS samples, and ensuring samples are sent to laboratories; v. interpreting the viral load results in relation to clearance to perform

EPPs vi. ensuring that the UKAP-OHR is updated in a timely manner vii. advising the HCW and the employer, on an ongoing basis, on

whether the HCW is fit to perform EPPs viii. timely liaison with treating physicians

C. Treating physician The treating physician is responsible for: i. the clinical management and support of the seropositive HCW ii. advising and maintaining timely communications with the consultant

occupational physician responsible for monitoring the infected HCW

Withdra

wn Feb

ruary

2021

13

4.1 Testing arrangements

Laboratory testing should be undertaken by a Clinical Pathology Accreditation

(UK) Limited accredited virology laboratoryvii.

The use of personal identifiers in requests for laboratory tests should be

avoided and care taken to ensure that the number of people who know the

HCW’s identity is kept to a minimum. However, full person identifiers must

always be used when sending results to the national UKAP-OHR.

Where coding is used, the occupational health physician, who maintains a full

identity record, should liaise with the lead consultant microbiologist/virologist

in the local laboratory to ensure a consistent coding system unique to that

laboratory is used, and that serial samples from the same HCW are

identifiable as such.

4.2 Breaks in monitoring

HIV infected HCWs who take a career break from performing EPPs may wish

to continue three monthly monitoring during this period to facilitate a return to

EPP activities. Individuals with a break in their monitoring record must meet

the criteria for initial clearance before returning to EPP activities.

4.3 Non-EPP HIV infected HCWs

HIV infected HCWs who do not perform EPPs but who continue to provide

clinical care to patients, must remain under regular medical and occupational

health supervision in accordance with good practice.

vii The turnaround time (TAT) for an HIV viral load test is subject to local agreement and will vary between laboratories. OH physicians should consider the TAT of their local laboratory when scheduling appointments for OH monitoring to ensure viral load results are available no later than 14 complete calendar weeks after the date of the preceding specimen taken for OH monitoring purposes.

Withdra

wn Feb

ruary

2021

14

5. Treatment issues

It is for the HCW to decide, in collaboration with their specialist treating

physician, whether they wish to take cART for occupational health reasons

when it is not clinically indicated, taking account of possible advantages and

disadvantages.

HCWs should be advised by their treating physician of the importance of

notifying them of missed doses, drug interactions or other factors that might

influence their viral load, as soon as is practicable and before further EPPs

are performed.

5.1 Management of treatment failure or suboptimal treatment response

If there is any suggestion that the HCWs infection is no longer controlled by

their antiretroviral treatment, the clinician overseeing their care may consider it

appropriate that viral load tests are performed sooner than the next three

month test.

A list of clinical experts who have agreed to provide advice to other treating

physicians and consultant occupational physicians on the clinical

management of HBV and HIV infected HCWs with breakthrough infection is

maintained by the UKAP Secretariat (see Appendix for contact details).

6. Patient notification exercises

Patient notification exercises for patients who have undergone EPP by an

untreated HIV infected HCW would take place according to current guidance

on HIV infected HCWs7.

Patient notification exercises connected with HIV infected HCWs on cART

would only be considered in circumstances in which their viral load had risen

above 1000 copies/ml. The need for patient notification would be determined

Withdra

wn Feb

ruary

2021

15

by a risk assessment on a case-by-case basis in line with the principles in

existing guidance, and the UKAP should be consulted for advice.

7. Management of patients following exposure to blood and body fluid of HIV infected HCW

There may be occasions when an HIV infected HCW is aware of accidentally

exposing a patient to their blood. HCWs should be advised of the action to

take in the event of this scenario.

The risk of transmission of BBV infection is directly related to the

concentration of the virus in the blood of the source at the time of exposure.

Exposure to the blood or body fluids of a HCW who is on continuous

antiretroviral therapy and has a low and stable HIV viral load is likely to pose

an extremely low risk of transmission.

In managing an incident in which an HIV infected HCW is aware of a patient

being exposed to their blood, the usual protocol for an occupational exposure

incident should be followed. The HCW should report the incident to the clinical

supervisor, line manager or other person responsible according to local

policies. A detailed risk assessment should be performed by the designated

doctor in discussion with the HCW’s consultant occupational physician and/or

the HCW’s treating physician, focussing on the adherence of the HCW to

treatment, the frequency (if any) of “blips” in the viral load and the presence of

factors which might raise the HCW’s viral load.

Where the exposure is considered non-significant, no further action is

required.

If the exposure was judged to be significant and the HCW has a stable low

viral load (less than 200 copies/ml), neither PEP nor follow-up HIV testing of

the patient is necessary. There is no reason to advise patients of a possible

Withdra

wn Feb

ruary

2021

16

exposure where the HCW was complying with the policy (ie had a viral load

less than 200 copies/ml) and was cleared for EPP work, as the risk of PEP

treatment far outweighs any risk of transmission

Where there is a concern that the viral load might be detectable (above 200

copies/ml), the HCW’s viral load should be tested immediately, PEP should be

offered to the patient pending the result, and the reasons for this explained to

the patient. PEP can be discontinued if the viral load is less than 200

copies/ml, the patient reassured, and no HIV testing would be required. If the

level is greater than 200 copies/ml, PEP should be continued for four weeks

and the patient tested at three months post PEP completion.

.

Withdra

wn Feb

ruary

2021

The Management of HIV infected Healthcare Workers: Elimination of exposure prone procedure HIV transmission risk from HIV infected Healthcare Workers

17

Appendix 1: Contacts

Clinical experts:

Professor Brian Gazzard e-mail: Brian.Gazzard@chelwest.nhs.uk tel: 020 8746 8239 Dr Keith Radcliffe e-mail: Keith.Radcliffe@uhb.nhs.uk tel: 0121 237 5719 Professor Clifford Leen e-mail: Clifford.Leen@nhslothian.scot.nhs.uk. tel: 0131 537 2852 UKAP Medical Secretary Dr Fortune Ncube e-mail: UKAP@phe.gov.uk or fortune.ncube@phe.gov.uk tel: 020 8327 6423

Withdra

wn Feb

ruary

2021

The Management of HIV infected Healthcare Workers: Elimination of exposure prone procedure HIV transmission risk from HIV infected Healthcare Workers

18

Reference List (1 ) Ciesielski C, Marianos D, Ou CY, Dumbaugh R, Witte J, Berkelman R, et al. Transmission

of human immunodeficiency virus in a dental practice. Ann Int Med 1992;116(10):798-805.

(2) Lot F, Seguier JC, Fegueux S, Astagneau P, Simon P, Aggoune M, et al. Probable transmission of HIV from an orthopedic surgeon to a patient in France. Ann Int Med 1999;130:1-6.

(3) Mallolas J, Arnedo M, Pumarola T, Erice A, Blanco J, Martinez E, et al. Transmission of HIV-1 from an obstetrician to a patient during a caesarean section. AIDS 2006;20:285-99.

(4) Goujon C, Scheider V, Grofti J, Montigny J, Jeantils V, Astagneau P, et al. Phylogenetic analyses indicte an atypical nurse-to-patient transmission of human immunodeficiency virus type 1. Journal of Virology 2000;74:2525-32.

(5) The Expert Advisory Group on HIV and AIDS, the Advisory Group on Hepatitis, The UK Advisory Panel for Healthcare Workers Infected with Bloodborne Viruses. The Report of the Tripartite Working Group, Management of HIV infected Healthcare Workers. 2011. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216126/dh_131574.pdf

(6) Department of Health. Health clearance for tuberculosis, hepatitis B, hepatitis C and HIV: New healthcare workers. Department of health; 2007. http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_074981.pdf

(7) Department of Health. HIV Infected Health Care Workers: guidance on management and patient notification. London; 2005. http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4116416.pdf

(8) Department of Health. HIV post-exposure prophylaxis. guidance from the UK Chief Medical Officers' Expert Advisory Group on AIDS. 2008. http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_089997.pdf

With

drawn F

ebrua

ry 20

21